ElectromyoneurographyUS ENMGNCT03868189
Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
A study testing Electroneuromyography with ultrasound and Electroneuromyography without ultrasound in people with Electromyoneurography, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electromyoneurography
- What is being tested?
- Electroneuromyography with ultrasound and Electroneuromyography without ultrasound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Apr 2019to 11 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
- Patient that has given his/her free and informed consent.
- Patient that signed the consent form.
- Patient with an health insurance plan.
- The patient is at least 18 years old (≥).
- he patient is under 80 years old (≤).
Who cannot join
- Patient with symptoms of neuropathy during the screening.
- Patient whose Neurological severity score (NSS) score is ≥ 3.
- Patient whose neurological examination is abnormal and suggestive of neuropathy.
- Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
- Patient already participating in a category 1 research study (Jardé law).
- Patient in an exclusion period determined by another study.
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- Patient under the protection of justice, under guardianship or under curatorship.
- Patient refusing to sign the consent form.
- Patient for which it is impossible to provide information about the study.
- Pregnant patient, parturient, or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
About this study
Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.
- Conditions
- Electromyoneurography
- Being tested
- Electroneuromyography with ultrasound, Electroneuromyography without ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroneuromyography with ultrasoundOther
Patients whose electroneuromyography examination will be performed using an ultrasound
Electroneuromyography without ultrasoundOther
Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)
| Study group | Role | What they receive |
|---|---|---|
| electroneuromyography | Experimental | Not described Receives: Other: Electroneuromyography with ultrasound |
| control | Placebo comparator | Not described Receives: Other: Electroneuromyography without ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves
unit : milliampere (mA)
Measured: Day 0
Secondary outcomes (9)
Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves
unit : mA
Measured: Day 0
Sensitivity Amplitude per collection site
unit : microvolts (uV)
Measured: Day 0
Motor Amplitude per collection site
unit : Millivolts (mV)
Measured: Day 0
Total number of explored muscles
unit : number
Measured: Day 0
Number of explored unusual muscles
unit : number
Measured: Day 0
Overall examination time between the beginning of the stimulation and the end of the myography examination
unit : minutes
Measured: Day 0
Average time per explored site (total duration divided by the number of explored nerves and muscles)
unit : minutes
Measured: Day 0
Score of satisfaction
Likert scale that range from 1 ("not satisfied at all ") to 4 ("totally satisfied")
Measured: Day 0
Measurement of felt pain
Analogical visual scale of pain from 1 (no pain) to 100 (maximum pain)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start4 Apr 2019
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElectromyoneurographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah COUDRAY, MD, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868189
- Sponsor's protocol ID
- NIMAO/2018-01/SC-01
- Other IDs
- 2018-A02872-53
- Acronym
- US ENMG
- Status last verified
- Aug 2021
- First submitted
- 7 Mar 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Favier-Archinard C, Leguelinel-Blache G, Dubois F, Le Gall T, Bourquard P, Passemard N, Tora S, Rey A, Rossi M, Chevallier T, Cousin C, Favier M. [Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Initial validation]. Bull Cancer. 2018 May;105(5):475-485. doi: 10.1016/j.bulcan.2017.12.011. Epub 2018 Mar 21. French.
PubMed 29573809Laure Inghilleri M, Alonso S, Moron H, Ruiz H, Bastide S, Coudray S. The value of ultrasound-guidance of nerves and muscles for patient tolerance and parameters electrodiagnostic studies. Clin Neurophysiol Pract. 2024 Jan 26;9:78-84. doi: 10.1016/j.cnp.2024.01.003. eCollection 2024.
PubMed 38357416
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03868189
- Acronym / sponsor ID
- US ENMG / NIMAO/2018-01/SC-01
- Conditions
- Electromyoneurography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroneuromyography | Experimental | Other: Electroneuromyography with ultrasound |
| control | Placebo comparator | Other: Electroneuromyography without ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination.
- Patient that has given his/her free and informed consent.
- Patient that signed the consent form.
- Patient with an health insurance plan.
- The patient is at least 18 years old (≥).
Key exclusion criteria (10 listed)
- Patient with symptoms of neuropathy during the screening.
- Patient whose Neurological severity score (NSS) score is ≥ 3.
- Patient whose neurological examination is abnormal and suggestive of neuropathy.
- Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.).
- Patient already participating in a category 1 research study (Jardé law).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroneuromyography with ultrasoundPatients whose electroneuromyography examination will be performed using an ultrasound | Other | electroneuromyography |
| Electroneuromyography without ultrasoundPatients whose electroneuromyography examination will be performed without ultrasound (fake tracking) | Other | control |
Primary outcome
Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves
Time frame: Day 0
unit : milliampere (mA)
9 secondary outcomes
Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves
Time frame: Day 0
Sensitivity Amplitude per collection site
Time frame: Day 0
Motor Amplitude per collection site
Time frame: Day 0
Total number of explored muscles
Time frame: Day 0
Number of explored unusual muscles
Time frame: Day 0
Overall examination time between the beginning of the stimulation and the end of the myography examination
Time frame: Day 0
Average time per explored site (total duration divided by the number of explored nerves and muscles)
Time frame: Day 0
Score of satisfaction
Time frame: Day 0
Measurement of felt pain
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 29573809Favier-Archinard C, Leguelinel-Blache G, Dubois F, Le Gall T, Bourquard P, Passemard N, Tora S, Rey A, Rossi M, Chevallier T, Cousin C, Favier M. [Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Initial validation]. Bull Cancer. 2018 May;105(5):475-485. doi: 10.1016/j.bulcan.2017.12.011. Epub 2018 Mar 21. French.
- Derived from this study: PubMed 38357416Laure Inghilleri M, Alonso S, Moron H, Ruiz H, Bastide S, Coudray S. The value of ultrasound-guidance of nerves and muscles for patient tolerance and parameters electrodiagnostic studies. Clin Neurophysiol Pract. 2024 Jan 26;9:78-84. doi: 10.1016/j.cnp.2024.01.003. eCollection 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah COUDRAY, MD principal investigator
Nîmes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroneuromyography with ultrasound and Electroneuromyography without ultrasound in people with Electromyoneurography, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03868189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.